Manufacturing Specialist for Biologic Production

3 days ago


San Antonio, Texas, United States Metric Bio Full time

We are collaborating with a leading biotechnology manufacturer, known for its innovation and commitment to regulatory excellence in San Antonio, TX.

About the Opportunity

The ideal candidate will support clinical and commercial manufacturing programs, adhering to cGMP standards and regulatory guidelines. Key responsibilities include:

  • Executing daily manufacturing activities for clinical and commercial manufacturing programs.
  • Documenting batch records following Good Documentation Practices (GDP).
  • Reviewing and revising SOPs, batch records, and manufacturing documentation.
  • Operating upstream and downstream processing equipment, including continuous flow centrifuges, depth filtration, chromatography, and HPLC systems.
  • Maintaining compliance with GMP, QA/QC policies, and regulatory requirements.
  • SUPPORTING deviation and CAPA resolution in collaboration with quality teams.
  • Assisting in MSAT/PD during development and scale-up activities.
  • Ensuring proper calibration and preventative maintenance of equipment.
  • Enforcing safety policies and ensuring compliance within the team.

Required Qualifications

  • Associate's, BS, or MS degree in a Scientific or Engineering discipline.
  • 4+ years (AS/BS) or 3+ years (MS) of experience in biomanufacturing.
  • Experience in microbial systems and cGMP environments is essential.
  • Strong understanding of Quality Management Systems and GMP principles.
  • Familiarity with upstream and downstream processing in a biomanufacturing setting.

Compensation: $80,000 - $110,000 per year



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